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Chemotherapy
Immunotherapy + Chemotherapy for Nasal and Sinus Cancer
Phase 2
Recruiting
Led By Bonnie Glission
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male participants: A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 150 days after the last dose of study treatment and refrain from donating sperm during this period.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will test if pembrolizumab, docetaxel, and cisplatin or carboplatin can effectively treat stage II-IVb squamous cell carcinoma of the PNS.
Who is the study for?
Adults with newly diagnosed, untreated Stage II-IVb squamous cell carcinoma of the nasal cavity/paranasal sinuses. Participants must have measurable disease, provide a tissue sample, not be pregnant or breastfeeding, agree to use contraception and have good organ function. Excludes those who've had prior cancer treatments for PNS SCC or immunotherapy.Check my eligibility
What is being tested?
The trial is testing a combination therapy (PDC) involving pembrolizumab (an immunotherapy drug) and chemotherapy drugs docetaxel and either cisplatin or carboplatin in patients with advanced squamous cancer of the nasal cavity/paranasal sinuses.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, nausea, hair loss from chemotherapy drugs docetaxel and platinum-based cisplatin/carboplatin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to follow the specified contraception guidelines and not donate sperm for 150 days after my last treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am mostly active and have good organ function.
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I am 18 or older with a new diagnosis of Stage II-IVb PNS SCC and have not started treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To increase overall response rate (ORR)
Secondary outcome measures
To determine the safety of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC
To determine the tolerability of pembrolizumab combined with induction chemotherapy and chemoradiation in patients with PNS SCC
To improve the following efficacy endpoints relative to historical results with chemotherapy alone
Trial Design
1Treatment groups
Experimental Treatment
Group I: pembrolizumab, docetaxel, and cisplatin or carboplatinExperimental Treatment4 Interventions
IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,996 Previous Clinical Trials
1,792,809 Total Patients Enrolled
Bonnie GlissionPrincipal InvestigatorM.D. Anderson Cancer Center
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
134 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to follow the specified contraception guidelines and not donate sperm for 150 days after my last treatment.I am fully active or restricted in physically strenuous activity but can do light work.My recent blood tests show my organs are functioning well.I have provided a recent or past biopsy of my tumor that was not treated with radiation.I am not pregnant, not breastfeeding, and either cannot become pregnant or agree to follow birth control guidelines.I am mostly active and have good organ function.I have been treated with specific immune therapy drugs before.I haven't had cancer treatment or radiation for PNS SCC, but may have for other cancers over 2 years ago.I am 18 or older with a new diagnosis of Stage II-IVb PNS SCC and have not started treatment.I am not pregnant, not breastfeeding, and either cannot become pregnant or agree to follow birth control guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: pembrolizumab, docetaxel, and cisplatin or carboplatin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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